N/A N=20 Randomized Treatment

Comparison of One-port and Two-port Tissue Expanders for Breast Reconstruction

Breast Cancer

Bottom Line

View on ClinicalTrials.gov: NCT02725801 ↗

Enrolled (actual)

Serious AEs

25.0%

Results posted

Sep 2020

Primary outcome: Primary: Number of Participants With Successful Replacement of Tissue Expander With Permanent Implant — 8; 12 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Allergen one-port tissue expander placement (Device); AlloX2 two-port tissue expander placement (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: Lesley Wong
Primary completion: Jul 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Successful Replacement of Tissue Expander With Permanent Implant	8; 12	—
SECONDARY Number of Participants Who Required Additional Intervention	1; 4	—

Summary

Appropriate patients undergoing going immediate breast reconstruction with tissue expanders following mastectomy will be randomized to receive one-port or two-ports tissue expanders. Their clinical course, complications, and outcome will be analyzed.

Eligibility Criteria

Inclusion Criteria

patient agrees to immediate tissue expander breast reconstruction
a suitable patient for tissue expander reconstruction

Exclusion Criteria

not a surgical candidate for immediate breast reconstruction
age less than 18
patient declines tissue expander reconstruction
patient anticipated to need radiation therapy postoperatively

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02725801). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.